What is surgery studying for Occult Tethered Cord Syndrome?

This trial is studying whether surgical release of the filum terminale can provide better symptom relief compared to medical management for patients with Occult Tethered Cord Syndrome. Researchers want to understand if surgery is a safe and more effective option. The study is sponsored by Weill Medical College of Cornell University.

Who may be eligible for this Occult Tethered Cord Syndrome clinical trial?

People aged 2 to 80 with OTCS symptoms that have not improved after at least one year of medical treatment may be eligible. Both males and females can join. Important factors include having a diagnosis confirmed by an OCCULT score of 30 or more and no prior lumbar spine surgeries. Please review eligibility criteria for more details.

Is there any cost to participate in this Occult Tethered Cord Syndrome clinical trial?

Study-related care, including the surgery or medical management and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly.

Actively Recruiting

Phase Not Applicable

Age: 2Years - 80Years

All Genders

ID05163899

Phase II Pilot Randomized-Controlled Trial of Surgical Release of the Filum Terminale Versus Medical Management in Treating Occult Tethered Cord Syndrome

Led by Weill Medical College of Cornell University · Updated on 2026-05-14

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating whether surgical release of the filum terminale, a fibrous tissue at the end of the spinal cord, provides better symptom relief than medical management in patients with Occult Tethered Cord Syndrome OTCS. This phase II pilot randomized-controlled trial aims to assess the preliminary effectiveness and safety of surgery compared to medical treatment for this condition. Participants will be randomly assigned to either undergo surgical untethering of the filum terminale or receive only medical management. Symptom improvement and any adverse events will be monitored and recorded for one year after treatment begins. After at least one year, patients initially receiving medical management may switch to surgery if the principal investigator considers it beneficial. Throughout the study, participants will have their symptoms evaluated using the OCCULT Scale at the start and after one year. Additional assessments include urologic and fecal incontinence scores, medication changes, and intra-operative findings during surgery. Safety and symptom changes will be carefully tracked for one year to understand the treatment effects and risks involved.

CONDITIONS

Brief Title

Investigation of Surgical Sectioning of the Filum Terminale in Treating Occult Tethered Cord Syndrome Patients

Who Can Participate

Age: 2Years - 80Years

All Genders

Eligibility Criteria

You may qualify if you...

Male or female aged 2 to less than 80 years
Symptoms refractory to medical management for at least 1 year
Diagnosis of OTCS with a total score of at least 30 on the OCCULT Grading Scale

You will not qualify if you...

Younger than 2 or older than 80 years
Radiographically identified tethered cord (low-lying conus at or below L2-3, thickened filum over 2 mm, fat in filum or lipoma, or clear tethering)
History of Meningocele manqué or Myelomeningocele
Cutaneous markings of dermal sinus tract
Prior surgery on the lumbar spine or for spinal dysraphism
History of central nervous system infection or autoimmune condition

Research Team

Cynthia Nguyen

Jeffrey Greenfield, MD, PhD

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